Aims: This open-label study examined the
efficacy and tolerability of risperidone in the treatment of
aggression, agitation, and psychotic symptoms in dementia. The
influence of risperidone on cognitive function was also assessed
under conditions reflecting normal, daily clinical care.

Method: A total of 34 hospital inpatients and
outpatients (mean age = 76 years) with DSM-IV dementia disorders
were treated with flexible doses of risperidone (0.5-2 mg/day)
for 8 weeks. Assessments, conducted at baseline and after weeks 4
and 8, included the Clinical Global Impressions scale (CGI) and
Neuropsychiatric Inventory (NPI) ratings. Cognitive function
assessments included the Mini-Mental State Examination (MMSE) and
specific measures of cognition (Age Concentration Test [AKT] and
Brief Syndrome Test [SKT]). Frequency of extrapyramidal symptoms
(EPS) was measured according to the Extrapyramidal Symptom Rating
Scale (ESRS).

Results:At the end of the study, 50% of
patients (N = 17) were receiving risperidone,1 mg/day, 18% (N =
6) were receiving 0.5 mg/day, and 32% (N = 11) received > 1
mg/day (mean dose at endpoint = 1.1 mg/day). An improvement in
symptoms, as measured by the CGI-Global Impression of Change
scale, was reported for 82% of patients (N = 28) (59% [N = 20]
much or very much improved). The frequency and severity of
delusions, hallucinations, agitation/aggression, and irritability
decreased as measured by the NPI. Multiplication of frequency and
severity scores revealed a significant decline during the course
of treatment (p < .001, end of study vs. baseline). Caregiver
responses on the NPI also showed an improvement, with the mean ±
SD total score decreasing from 24.2 ± 7.3 at baseline to 21.2 ±
6.3 at study end (p = .002). MMSE, AKT, and SKT results indicated
that there was no decrease in cognitive function during the
study. Risperidone treatment was well tolerated, and no
clinically relevant changes in EPS, vital signs, or weight were
detected.

Conclusion: During treatment with low-dose
risperidone, behavioral and psychological symptoms improved
overall in 34 patients with dementia, and cognitive function was
maintained throughout the treatment period.